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Is funding source related to study reporting quality in obesity or nutrition randomized control trials in top-tier medical journals?

ABSTRACT: Faithful and complete reporting of trial results is essential to the validity of the scientific literature. An earlier systematic study of randomized controlled trials (RCTs) found that industry-funded RCTs appeared to be reported with greater quality than non-industry-funded RCTs. The aim of this study was to examine the association between systematic differences in reporting quality and funding status (that is, industry funding vs non-industry funding) among recent obesity and nutrition RCTs published in top-tier medical journals.Thirty-eight obesity or nutrition intervention RCT articles were selected from high-profile, general medical journals (The Lancet, Annals of Internal Medicine, JAMA and the British Medical Journal) published between 2000 and 2007. Paired papers were selected from the same journal published in the same year, one with and the other without industry funding. The following identifying information was redacted: journal, title, authors, funding source and institution(s). Then three raters independently and blindly rated each paper according to the Chalmers method, and total reporting quality scores were calculated.The inter-rater reliability (Cronbach's alpha) was 0.82 (95% confidence interval = 0.80-0.84). The total mean (M) and s.d. of Chalmers Index quality score (out of a possible 100) for industry-funded studies were M = 84.5, s.d. = 7.04 and for non-industry-funded studies they were M = 79.4, s.d. = 13.00. A Wilcoxon matched-pairs signed-ranks test indicates no significant rank difference in the distributions of total quality scores between funding sources, Z = -0.966, P = 0.334 (two tailed).Recently published RCTs on nutrition and obesity that appear in top-tier journals seem to be equivalent in quality of reporting, regardless of funding source. This may be a result of recent reporting of quality statements and efforts of journal editors to raise all papers to a common standard.

SUBMITTER: Kaiser KA

PROVIDER: S-EPMC3288675 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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Is funding source related to study reporting quality in obesity or nutrition randomized control trials in top-tier medical journals?

Kaiser K A KA Cofield S S SS Fontaine K R KR Glasser S P SP Thabane L L Chu R R Ambrale S S Dwary A D AD Kumar A A Nayyar G G Affuso O O Beasley M M Allison D B DB

International journal of obesity (2005) 20111108 7

<h4>Background</h4>Faithful and complete reporting of trial results is essential to the validity of the scientific literature. An earlier systematic study of randomized controlled trials (RCTs) found that industry-funded RCTs appeared to be reported with greater quality than non-industry-funded RCTs. The aim of this study was to examine the association between systematic differences in reporting quality and funding status (that is, industry funding vs non-industry funding) among recent obesity a ...[more]

PMID: 22064159

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Project description:ObjectivesTo assess how often stratified randomisation is used, whether analysis adjusted for all balancing variables, and whether the method of randomisation was adequately reported, and to reanalyse a previously reported trial to assess the impact of ignoring balancing factors in the analysis.DesignReview of published trials and reanalysis of a previously reported trial.SettingFour leading general medical journals (BMJ, Journal of the American Medical Association, Lancet, and New England Journal of Medicine) and the second Multicenter Intrapleural Sepsis Trial (MIST2).Participants258 trials published in 2010 in the four journals. Cluster randomised, crossover, non-randomised, single arm, and phase I or II trials were excluded, as were trials reporting secondary analyses, interim analyses, or results that had been previously published in 2010.Main outcome measuresWhether the method of randomisation was adequately reported, how often balanced randomisation was used, and whether balancing factors were adjusted for in the analysis.ResultsReanalysis of MIST2 showed that an unadjusted analysis led to larger P values and a loss of power. The review of published trials showed that balanced randomisation was common, with 163 trials (63%) using at least one balancing variable. The most common methods of balancing were stratified permuted blocks (n=85) and minimisation (n=27). The method of randomisation was unclear in 37% of trials. Most trials that balanced on centre or prognostic factors were not adequately analysed; only 26% of trials adjusted for all balancing factors in their primary analysis. Trials that did not adjust for balancing factors in their analysis were less likely to show a statistically significant result (unadjusted 57% v adjusted 78%, P=0.02).ConclusionBalancing on centre or prognostic factors is common in trials but often poorly described, and the implications of balancing are poorly understood. Trialists should adjust their primary analysis for balancing factors to obtain correct P values and confidence intervals and to avoid an unnecessary loss in power.

Project description:BackgroundThe source of funding is one of many possible causes of bias in scientific research. One method of detecting potential for bias is to evaluate the quality of research reports. Research exploring the relationship between funding source and nutrition-related research report quality is limited and in other disciplines the findings are mixed.ObjectiveThe purpose of this study is to determine whether types of funding sources of nutrition research are associated with differences in research report quality.DesignA retrospective study of research reporting quality, research design and funding source was conducted on 2539 peer reviewed research articles from the American Dietetic Association's Evidence Analysis Library® database.ResultsQuality rating frequency distributions indicate 43.3% of research reports were rated as positive, 50.1% neutral, and 6.6% as negative. Multinomial logistic regression results showed that while both funding source and type of research design are significant predictors of quality ratings (?2?=?118.99, p?0.001), the model's usefulness in predicting overall research report quality is little better than chance. Compared to research reports with government funding, those not acknowledging any funding sources, followed by studies with University/hospital funding were more likely to receive neutral vs positive quality ratings, OR?=?1.85, P <0.001 and OR?=?1.54, P<0.001, respectively and those that did not report funding were more likely to receive negative quality ratings (OR?=?4.97, P<0.001). After controlling for research design, industry funded research reports were no more likely to receive a neutral or negative quality rating than those funded by government sources.ConclusionResearch report quality cannot be accurately predicted from the funding source after controlling for research design. Continued vigilance to evaluate the quality of all research regardless of the funding source and to further understand other factors that affect quality ratings are warranted.

Project description:BackgroundRandomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field.MethodsIn June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0.ResultsIn total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score.ConclusionsThe completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

Project description:ObjectivesTo describe and summarise how the results of randomised controlled trials (RCTs) that did not find a significant treatment effect are reported, and to estimate how commonly trial reports make unwarranted claims.DesignWe performed a retrospective survey of published RCTs, published in four high impact factor general medical journals between June 2016 and June 2017.SettingTrials conducted in all settings were included.Participants94 reports of RCTs that did not find a difference in their main comparison or comparisons were included.InterventionsAll interventions.Primary and secondary outcomesWe recorded the way the results of each trial for its primary outcome or outcomes were described in Results and Conclusions sections of the Abstract, using a 10-category classification. Other outcomes were whether confidence intervals (CIs) and p values were presented for the main treatment comparisons, and whether the results and conclusions referred to measures of uncertainty. We estimated the proportion of papers that made claims that were not justified by the results, or were open to multiple interpretations.Results94 trial reports (120 treatment comparisons) were included. In Results sections, for 58/120 comparisons (48.3%) the results of the study were re-stated, without interpretation, and 38/120 (31.7%) stated that there was no statistically significant difference. In Conclusions, 65/120 treatment comparisons (54.2%) stated that there was no treatment benefit, 14/120 (11.7%) that there was no significant benefit and 16/120 (13.3%) that there was no significant difference. CIs and p values were both presented by 84% of studies (79/94), but only 3/94 studies referred to uncertainty when drawing conclusions.ConclusionsThe majority of trials (54.2%) inappropriately interpreted a result that was not statistically significant as indicating no treatment benefit. Very few studies interpreted the result as indicating a lack of evidence against the null hypothesis of zero difference between the trial arms.

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Is funding source related to study reporting quality in obesity or nutrition randomized control trials in top-tier medical journals?

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Is funding source related to study reporting quality in obesity or nutrition randomized control trials in top-tier medical journals?

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